Over the past several weeks, as the federal government and state governments have ramped up their efforts to combat the spread of COVID-19, there have been a slew of legal and regulatory developments concerning telehealth. These developments are generally aimed at helping ensure patients can remain at home without jeopardizing their access to critical services. However, many of these changes have neglected to include a critical resource that can help in the battle against COVID-19: pharmacists. Telepharmacists could be a vital resource for managing patients with chronic disease by addressing medication related issues that are potentially being ignored by patients appropriately concerned about accessing overburdened COVID infested care delivery organizations. In this blog, we will give a brief overview of recent telehealth laws and regulations, and then discuss the missed opportunity of including pharmacist in them.
What's New in Telehealth Rules
Below are a few of the most significant developments concerning telehealth laws and regulations you should know.
1. Improved access to telehealth services
In March, the Centers for Medicare & Medicaid Services greatly broadened access to Medicare telehealth services with the issuing of the 1135 waiver. Under this waiver, Medicare now pays for office, hospital, and other visits furnished via telehealth across the country, including in patient's places of residence (as of March 6, 2020). Additionally, the U.S. Department of Health & Human Services (HHS) Office of Inspector General permitting providers to reduce or waive cost-sharing for telehealth visits paid by federal healthcare programs.
This waiver greatly expanded the reach of telehealth, at least temporarily. Prior to the waiver, Medicare would only pay for telehealth when a patient receiving the service was in a designated rural area and when they went to a clinic, hospital, or certain other types of medical facilities for the service.
2. Expansion of state licensure
In mid-March, HHS announced it was allowing healthcare providers to practice across state lines. This decision was the first step toward removing a significant barrier (again, at least temporarily) to the continued adoption of telehealth as it indicated that physicians would be permitted to conduct telehealth consults with patients residing in states where those doctors are not licensed. At the time of the announcement, there was no accompanying regulation, but that has since changed.
The Centers for Medicare & Medicaid Services (CMS) issued temporary measures allowing providers to practice remote care, even across state lines, through telehealth. Since the ruling did not eliminate interstate licensing entirely, Secretary of HHS Alex Azar sent a letter and guidance to governors that included a request that they "Waive restrictions, on a temporary basis (during the emergency period), on health providers licensed, registered, or certified in good standing with another state," and "To the extent permissible, waive statutes and regulations mandating telehealth modalities and/or practice standards not necessary for the applicable standard of care to establish a patient-provider relationship, diagnose, and deliver treatment recommendations utilizing telehealth technologies."
Most states have issued some form of a waiver, notes the Federation of State Medical Boards, which is tracking how states are modifying in-state licensure requirements for telehealth in response to the pandemic.
3. New patient eligibility
By the end of March, HHS had waived telehealth requirements in several areas. As the American Society of Health-System Pharmacists (ASHP) noted, this included patient and service eligibility. "Both new and existing patients may now access telehealth for a wide range of services. Previously, telehealth was available for a fairly limited range of services and required that the provider or another practitioner within the provider's practice had provided telehealth services to the patient within the past three years. Now, new patients can receive telehealth services."
4. Greater billing flexibility
One final noteworthy telehealth law change concerns billing. Also falling under the 1135 waiver, providers can use telecommunication technology to deliver office, hospital visits, and other services to Medicare patients that generally occur in-person and bill for these services at the same level as if they had been provided in person. Providers must use an interactive audio and video telecommunications system permitting real-time communication between the site and patient at home.
Impact on Telepharmacy
If you are thinking about launching a telepharmacy program or growing an existing one, these are some of the key takeaways from telehealth law changes. ASHP states that its understanding was that while pharmacists can provide telehealth services "incident to" a Medicare-eligible provider, they cannot yet directly bill Medicare for these services. Unfortunately, this is a missed opportunity to provide further resources in the fight against COVID-19.
Provider Status for Pharmacists: A Much-Needed Change
While the above legal and regulatory changes are good news for providers and patients, legislators have thus far come up short in addressing what would be a valuable development: granting pharmacists provider status. Despite lobbying by a coalition of pharmacy stakeholders, coronavirus legislation has yet to include pharmacist provider status language.
A letter from Steven Anderson, president and chief executive officer of the National Association of Chain Drug, to members of the federal government and U.S. Congress, argued the following: "Establishing pharmacists as providers in Medicare Part B can further bolster an important access point for care for those afflicted by COVID-19 as well as supplement a national health care system that may be severely overtaxed by the response to the virus. The (HHS) Secretary should authorize that pharmacists be recognized as providers under Medicare Part B subject to state scope of practice laws in order to assist in the response to the COVID-19 outbreak."
As a Drug Topics article notes, "Pharmacists are already classified as providers in most states … But what that means depends on just where in state law pharmacists are classified as providers. It depends on pharmacists' scope of practice under state law. And most importantly, it also depends on what states do or do not require in terms of reimbursement for pharmacist services."
At a time when the country has an overstretched workforce and an oversupply of pharmacists, granting provider status to pharmacists and the consequent ability to bill CMS and commercial payers would allow pharmacists to play an even greater role in the effort to end the pandemic.
In a recent pharmacy organizations' joint policy statement, they advocate that pharmacists be utilized as frontline responders for COVID-19 patient care. The statement notes that "Pharmacists are the most accessible healthcare providers and the first touchpoint of patient engagement with the healthcare system. … Pharmacists are trained to treat infectious diseases and can significantly expand access to care, if barriers are removed."
The statement goes on to discuss that pharmacists can help with COVID-19 response by "… administering tests, treating COVID-19 when treatments become available, and by testing for and treating influenza and strep throat infections… [to] alleviate some of the burden on hospitals and clinics so they can focus on high-risk COVID-19 patients."
They are urging legal and regulatory authorities to implement the following recommendations:
- Authorize test-treat-immunize: Authorize additional pharmacist-provided services.
- Ease operational barriers: Address workforce and workflow issues that prevent full and effective pharmacist engagement in COVID-19 response.
- Address shortages and continuity of care: Remove barriers for pharmacists to provide viable alternatives if a particular medication’s supply chain is interrupted.
- Reimburse for services: Remove reimbursement barriers that prevent pharmacists from fully and effectively engaging in COVID-19 response.
Signatories on this joint statement include the American Pharmacists Association, ASHP, and the American Association of Colleges of Pharmacy. We hope that continued advocacy and lobbying for including pharmacists and their services into future telehealth-related legislation will motivate lawmakers to address what we consider a grave oversight.
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